Impingement SyndromeNCT06655714
Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome
An observational study of Impingement Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the impact of central sensitization in patients with shoulder impingement syndrome who have shown an inadequate response to ultrasound-guided subacromial corticosteroid injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Impingement Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 72 patients aged 18-65 who have been diagnosed with shoulder impingement syndrome and have undergone ultrasound-guided subacromial corticosteroid injection.
Who may be able to join
- Patients aged 18-65.
- Diagnosed with shoulder impingement syndrome.
- Received ultrasound-guided subacromial corticosteroid injection.
- Experienced shoulder pain for at least 6 months.
Who cannot join
- History of surgery or fracture in the shoulder or related areas.
- Presence of an active infection.
- Received shoulder injection within the last 6 months.
- Underwent physical therapy for the shoulder in the last 6 months.
- Presence of other musculoskeletal or neurological conditions that could cause shoulder pain (e.g., cervical disc herniation, stenosis, moderate to severe osteoarthritis, adhesive capsulitis, rheumatologic pathologies, infectious joint diseases).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization?
The aim of this study is to investigate the impact of central sensitization in patients with shoulder impingement syndrome who have shown an inadequate response to ultrasound-guided subacromial corticosteroid injection. Additionally, the patients' pain perception and emotional state will be evaluated, and the relationships between these factors and the treatment response will be analyzed.
Read the detailed description
Seventy-two patients aged 18-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital, diagnosed with shoulder impingement syndrome based on magnetic resonance imaging (MRI), and who received ultrasound-guided corticosteroid injection, will be included in the study. No additional interventions or procedures will be performed for the research. These patients, who were previously assessed and treated in the outpatient clinic, will be invited for a follow-up examination at the 4th week after the injection. During the follow-up, their response to the treatment will be evaluated using the Visual Analog Scale (VAS). A reduction of less than 50% on the VAS by the end of the 4th week will be considered an inadequate response. Patients with inadequate and good responses will be divided into two groups and assessed for central sensitization, pain perception, and emotional state. Central sensitization will be evaluated using the Central Sensitization Inventory (CSI), and hyperalgesia will be assessed using an algometer to measure pressure-pain threshold. Additionally, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale will be used to determine the patients' emotional state and pain perception.
- Conditions
- Impingement Syndrome
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with adequate response | In this study, patients whose Visual Analog Scale (VAS) score decreases by 50% or more after 4 weeks of receiving the ultrasound-guided corticosteroid injection will be considered to have had an adequate response. Receives: Other: No intervention | |
| Patients with inadequate response | In this study, an inadequate response is defined as less than a 50% reduction in pain, as measured by the Visual Analog Scale (VAS), four weeks after the ultrasound-guided corticosteroid injection. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale is a tool used to measure the intensity of pain. It consists of a 10 cm line, where one end represents "no pain" (0) and the other end represents "worst imaginable pain" (10). Patients mark the point on the line that reflects their current pain level. In this study, a reduction of less than 50% on the VAS after 4 weeks is considered an inadequate response to the treatment.
Measured: 0 day, 4th week
Central Sensitization Inventory (CSI)
The CSI is a self-reported questionnaire used to identify the presence of central sensitization, which is a condition where the central nervous system becomes hypersensitive to stimuli. It consists of 25 items that measure symptoms related to central sensitization syndromes. Higher scores indicate a greater likelihood of central sensitization, which can contribute to persistent pain in conditions like shoulder impingement syndrome.
Measured: 0 day, 4th week
Pressure-Pain Threshold (PPT) Using Algometer
The Pressure-Pain Threshold is the minimum force applied to the skin that induces pain. In this study, an algometer is used to measure PPT at various points on the body. Lower PPT values indicate increased sensitivity to pressure, which is a sign of hyperalgesia, often associated with central sensitization.
Measured: 0 day, 4th week
Pain Catastrophizing Scale (PCS):
The PCS is a psychological tool used to assess the extent to which individuals experience catastrophic thoughts related to their pain. It includes 13 items that measure rumination, magnification, and helplessness in response to pain. Higher scores on the PCS suggest that the patient tends to catastrophize pain, which can negatively affect their pain experience and recovery.
Measured: 0 day, 4th week
Hospital Anxiety and Depression Scale (HADS):
The HADS is a questionnaire used to assess the emotional state of patients, focusing on anxiety and depression. It consists of 14 items, divided into two subscales: one for anxiety (HADS-A) and one for depression (HADS-D). Higher scores indicate greater levels of anxiety or depression, which can influence how patients perceive and cope with their pain.
Measured: 0 day, 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start15 Oct 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655714
- Sponsor's protocol ID
- BeylikduzuStateH7
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sirin Ahisha B, Paker N, Kesiktas N, Bugdayci ND, Ahisha YC. Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization? Arch Phys Med Rehabil. 2025 Aug;106(8):1227-1237. doi: 10.1016/j.apmr.2025.01.469. Epub 2025 Feb 1.
PubMed 39900325
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization?
- ClinicalTrials.gov ID
- NCT06655714
- Acronym / sponsor ID
- BeylikduzuStateH7
- Conditions
- Impingement Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the impact of central sensitization in patients with shoulder impingement syndrome who have shown an inadequate response to ultrasound-guided subacromial corticosteroid injection. Additionally, the patients' pain perception and emotional state will be evaluated, and the relationships between these factors and the treatment response will be analyzed.
Detailed description
Seventy-two patients aged 18-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital, diagnosed with shoulder impingement syndrome based on magnetic resonance imaging (MRI), and who received ultrasound-guided corticosteroid injection, will be included in the study. No additional interventions or procedures will be performed for the research. These patients, who were previously assessed and treated in the outpatient clinic, will be invited for a follow-up examination at the 4th week after the injection. During the follow-up, their response to the treatment will be evaluated using the Visual Analog Scale (VAS). A reduction of less than 50% on the VAS by the end of the 4th week will be considered an inadequate response. Patients with inadequate and good responses will be divided into two groups and assessed for central sensitization, pain perception, and emotional state. Central sensitization will be evaluated using the Central Sensitization Inventory (CSI), and hyperalgesia will be assessed using an algometer to measure pressure-pain threshold. Additionally, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale will be used to determine the patients' emotional state and pain perception.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with adequate response | – | Other: No interventionIn this study, patients whose Visual Analog Scale (VAS) score decreases by 50% or more after 4 weeks of receiving the ultrasound-guided corticosteroid injection will be considered to have had an adequate response. |
| Patients with inadequate response | – | Other: No interventionIn this study, an inadequate response is defined as less than a 50% reduction in pain, as measured by the Visual Analog Scale (VAS), four weeks after the ultrasound-guided corticosteroid injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 72 patients aged 18-65 who have been diagnosed with shoulder impingement syndrome and have undergone ultrasound-guided subacromial corticosteroid injection.
Key inclusion criteria (4 listed)
- Patients aged 18-65.
- Diagnosed with shoulder impingement syndrome.
- Received ultrasound-guided subacromial corticosteroid injection.
- Experienced shoulder pain for at least 6 months.
Key exclusion criteria (5 listed)
- History of surgery or fracture in the shoulder or related areas.
- Presence of an active infection.
- Received shoulder injection within the last 6 months.
- Underwent physical therapy for the shoulder in the last 6 months.
- Presence of other musculoskeletal or neurological conditions that could cause shoulder pain (e.g., cervical disc herniation, stenosis, moderate to severe osteoarthritis, adhesive capsulitis, rheumatologic pathologies, infectious joint diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with adequate response, Patients with inadequate response |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 0 day, 4th week
The Visual Analog Scale is a tool used to measure the intensity of pain. It consists of a 10 cm line, where one end represents "no pain" (0) and the other end represents "worst imaginable pain" (10). Patients mark the point on the line that reflects their current pain level. In this study, a reduction of less than 50% on the VAS after 4 weeks is considered an inadequate response to the treatment.
Central Sensitization Inventory (CSI)
Time frame: 0 day, 4th week
The CSI is a self-reported questionnaire used to identify the presence of central sensitization, which is a condition where the central nervous system becomes hypersensitive to stimuli. It consists of 25 items that measure symptoms related to central sensitization syndromes. Higher scores indicate a greater likelihood of central sensitization, which can contribute to persistent pain in conditions like shoulder impingement syndrome.
Pressure-Pain Threshold (PPT) Using Algometer
Time frame: 0 day, 4th week
The Pressure-Pain Threshold is the minimum force applied to the skin that induces pain. In this study, an algometer is used to measure PPT at various points on the body. Lower PPT values indicate increased sensitivity to pressure, which is a sign of hyperalgesia, often associated with central sensitization.
Pain Catastrophizing Scale (PCS):
Time frame: 0 day, 4th week
The PCS is a psychological tool used to assess the extent to which individuals experience catastrophic thoughts related to their pain. It includes 13 items that measure rumination, magnification, and helplessness in response to pain. Higher scores on the PCS suggest that the patient tends to catastrophize pain, which can negatively affect their pain experience and recovery.
Hospital Anxiety and Depression Scale (HADS):
Time frame: 0 day, 4th week
The HADS is a questionnaire used to assess the emotional state of patients, focusing on anxiety and depression. It consists of 14 items, divided into two subscales: one for anxiety (HADS-A) and one for depression (HADS-D). Higher scores indicate greater levels of anxiety or depression, which can influence how patients perceive and cope with their pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 39900325Sirin Ahisha B, Paker N, Kesiktas N, Bugdayci ND, Ahisha YC. Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization? Arch Phys Med Rehabil. 2025 Aug;106(8):1227-1237. doi: 10.1016/j.apmr.2025.01.469. Epub 2025 Feb 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impingement Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 0 day, 4th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.